Cook Biotech, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0834-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile

Product Classification:

Class II

Date Initiated: November 22, 2024

Date Posted: January 22, 2025

Recall Number: Z-0834-2025

Event ID: 95961

Reason for Recall:

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

Status: Ongoing

Product Quantity: 10 devices

Code Information:

Lot #LB1581197, exp. 2/4/2026, Box UDI-DI 10827002310916; Pouch UDI-DI 00827002310919.

Distribution Pattern:

US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.

Voluntary or Mandated:

Voluntary: Firm initiated